Here Come Generics -- Test Strips and a New All-In-One Meter

Written by Mike Hoskins
| Published on April 17, 2014

It almost seems that a new era of alternative test strips and other "basic" diabetes products has hit. It's a sign of the times, really, as big-name brands are hurting because of Medicare competitive bidding changes that are limiting access to pricier products in favor of more economical options -- giving producers of generics a fresh entry point into the market.

Last week, a company called UniStrip Technologies announced availability of a new FDA-approved generic test strip, and at the same time, we got word that the green-colored GenStrip alternative test strip we reported on in late 2012 is ramping up marketing after some courtroom successes against Johnson and Johnson's family of LifeScan and OneTouch glucose meters (yes, they were being sued for patent infringement).

On top of that, we learned that the company behind the GenStrip is now developing its own new all-inclusive wireless glucose meter that has strips, a lancet and smartphone app connectivity all weaved into one device, called the Discretion.

These simplified products offer affordability, but perhaps a trade-off in terms of quality of care... We looked into all three to bring you the scoop.

Note that these two new brands of generic strips work with some of the best-selling meter models made by LifeScan:

Questioning the New UniStrip

In early April, a new UniStrip generic made its way to the U.S. market after snagging FDA approval in November.

You can buy a 50-count box of these strips for about $12 on eBay and Amazon right now (something I'm personally hesitant to do, because it seems shady to me) and in the coming months we're told these strips will start appearing on pharmacy shelves and even in big-name retail stores, where we're told they'll sell for somewhere around $9-10.

Developed by newly formed North Carolina-based UniStrip Technologies, they work with the LifeScan OneTouch Ultra family of meters -- but ONLY those made and/or purchased before Oct. 2012, according to the FDA approval statement for this generic strip.

CEO Rick Admani is the man behind UniStrip Technologies. He also happens to be the chief operating officer of Prodigy Diabetes Care that makes the talking glucose meter for the vision impaired and other "off-brand" glucose meters. Admani tells us the two companies are legally separate entities and not related, despite his executive role at both, and the fact that they are located within just 7 miles of each other in North Carolina, share the same general counsel and FDA consultant who applied for regulatory approval of products, and they both use the same marketing agent.

Why does any of that matter? Well, patient advocates like those behind StripSafely meter accuracy campaign and others in the Diabetes Community have been quite vocal with criticisms of Prodigy products due to some struggles with the FDA over the past year or so, most recently with the FDA calling out a Prodigy meter as being less accurate than others on the market and attaching unique and never-before-seen labeling requirements to a product approval.

So, if this same company putting out questionable quality is now making generic strips, that's something we consumers need to be aware of -- even if the concerns have been addressed and signed off on by regulators, which Prodigy says they have. You be the judge. But honestly to us, customer trust has been compromised here...

Despite that controversy, Admani insists that UniStrip generics are as accurate if not more accurate than leading brand-name products. He says UniStrips meet both the existing FDA rules and also the 2013-enacted ISO guidelines. His company is also engaged in regular conversation with LifeScan, he says, and even revised its generic strip packaging some to appease the big manufacturer and ward off any potential litigation.

Admani tells us they're also developing at least three more UniStrip generics to work with other meters, beyond just the J&J brands.

"We're the new player, and so of course we're the ones that the big manufacturers are going to raise questions about," he said. "But this is a new change in this diabetes world, and it feels like we're going to see more new generic strips. It's going to change the game."

Of course, this isn't the first alternative test strip to make headlines...

It got FDA clearance in November 2012, but the brakes were applied on getting those to patients when J&J sued its parent company Decision Diagnostics claiming patent infringement.

That litigation is still ongoing and PharmaTech lost at the lowest federal court level, but as it turns out the past year has been mostly positive for PharmaTech -- the biggest boost being that an appeals court panel overturned an injunction that had prevented the GenStrip from actually being sold.

Chief Financial Officer Keith Berman tells us that the recent Medicare competitive-bidding changes have caused PharmaTech Solutions to revise its business model; instead of selling directly to patients, the company is now targeting local pharmacies. Indeed, GenStrips can now be found on smaller pharmacy shelves and online at Amazon and eBay for around $15-18.

"The direct-to-consumer mail order market place has pretty much died, and we're surprised by that. Some companies have even disappeared, and it's gone to brick-and-mortar pharmacies where patients go to pay co-pays and pick up their strips," he said. "Pharmacies are under contract, and Medicare bills the patient directly. So, that's presented a huge opportunity for us."

Just this week, parent company Decision Diagnostics announced that it had acquired the GenStrip and all its trademarking rights from the original company, Shasta Technologies, following a new advertisement that started airing last month in select parts of the country (and they say another new one should be debuting before long):

So, it looks like GenStrip is hitting the market at full speed.... but is it keeping pace with ongoing concerns about accuracy within the regulatory world and patient community?

Talking Test Strip Accuracy

This topic has gained a lot of steam in the past year, with the pending FDA draft guidelines on accuracy still open for public commentary until May 7, 2014. In those guidelines, the FDA has specific language addressing quality measures third-party strip makers and that's something we, as a D-Community, should be supporting.

When asked about accuracy, both UniStrip and GenStrip developers cite big brand name manufacturer recalls and say they expect none of those. And they quickly downplay any concerns about quality, insisting that their products meet current accuracy rules, but at more affordable prices.

Published data on the new UniStrip shows those generic strips do fall within the existing and proposed rules just like most of the current competing products from big-name manufacturers.

But we didn't get the same "pro-accuracy vibe" when it comes to GenStrip. CFO Berman tells us that GenStrips do meet the existing FDA standard of falling within 20% of accuracy benchmarks most of the time, but he said the strips fall just short of the 2013 ISO standard and the new draft FDA rules. Yes, GenStrip data shows that 93% of the time the GenStrips are within +/- 15%, but the FDA's draft rules call for 99% be within that range when glucose levels are 75 mg/dL or above. Yet according to Berman, the company's not concerned with beefing up accuracy to meet those standards, if it's not required to do so.

"GenStrip is already cleared (by FDA)," Berman told us. "We do not have to make GenStrip comply to the new guidance -- which is only for new filings, not previously cleared filings."

Uh, huh. Well, good to know that GenStrips will meet the minimum requirement at least. And regarding quality assurance, Berman did mention that while FDA's existing guidelines call for a 95% success rate for new lots of strips to be released, GenStrip actually shoots for 97% each time.

Not surprisingly, neither company had much to say about the notion of post-market surveillance (checks to make sure existing products remain accurate), that patients have also been pushing for with the StripSafely campaign.

All-In-One Glucose Meter in the Works

PharmaTech is going beyond the GenStrip and actually developing a new all-inclusive combo meter with the ability to transmit test results wirelessly and securely to any cell phone device that supports text messaging, Berman tells us.

Called the Discretion (awkward name?), it would not use the GenStrips since those designed specifically for OneTouch Ultra meters. So another set of proprietary strips would be necessary.

The meter itself almost looks like an old-school Walkman cassette player from the 80s and 90s, yet Berman tells us the size is "small enough to fit into an 11-year-old's hand." It would have a lancet device built in and a replaceable cartridge of test strips inside, all self-contained.

This Discretion meter's actually being developed with kids older than 10 in mind, but Berman says it could also be a big seller for PWDs who travel a lot or who don't want to carry a full test kit around everywhere. The data could be sent by text message to up to 5 smartphones automatically and a free app would allow you to view that D-data.

The vision is to have this product showcased in big-name retail stores where it could be even be displayed at check out aisles, selling for $29.95 and you could buy replacement strips in an 8-10 pack for $4.95, Berman tells us, adding that clinical studies are expected to start in May, and they expect to file with FDA directly once those studies are complete.

And when it comes to generics, there are always reservations about quality and accuracy. We have seen the manufacturing facilities of many large Pharma companies up close and personal and had in-depth conversations that illustrate the justification for higher test strip costs (i.e. the enzymes, precious metals, chemicals, and other materials that make up the strips, plus the burden of building and maintaining manufacturing plants). And despite recalls that pop up periodically, we have to admit that it's comforting at times knowing there's some credibility in the manufacturing process behind the products we're buying.

That said, as long as these new generic strips and off-brand meters are meeting accuracy requirements and providing quality that meets patient needs, then there's no reason we can't also be excited about these new, lower-cost options.

** UPDATE #1 - April 29, 2014: The U.S. FDA issued a safety warning about the GenStrips, saying they may produce inaccurate readings and shouldn't be used. A recent FDA inspection of the manufacturing facility found "extensive violations" and found that many of the requirements for a quality system weren't in place. To date, the company's been unwilling to voluntarily recall their test strips and so the FDA advices everyone to stop using these generic strips.

** UPDATE #2 - April 30, 2014: In a response to the FDA warning, Decision Diagnostics and its subsidiary PharmaTech Solutions that acquired the GenStrip in mid-March says it will replace all of the older GenStrips produced by the previous owner, Shasta Technologies. They've also rebranded the strip as PharmaTech GenStrip 50.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community.
The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines.
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Archived Comments

StephenS|2014-04-17

Mike... great report. Thanks for doing all this tedious research. Makes me want to look into these companies a bit more. Thanks

Brent|2014-04-17

I'm a regular reader of 'the Mine', and have a couple of issues with this article.Yes accuracy is a concern, but cost of test strips is an equal concern. We've all been screaming about the non-availability of generic test strips forever, and now it seems you are pooh-poohing it right when these are coming out?These strips were approved by the FDA and so would be at least as accurate as the current strips for the OneTouch meters for 10% of the cost. That is HUGE, particularly for some of us whose insurance is now limiting the number of strips they'll pay for in a month (mine is 207).Also, the veiled xenophobic reference to Taiwan was cheap. Taiwan (different from mainland China) produces some of the highest quality electronic and scientific equipment anywhere in the world.More information on generic test strips would be appreciated. Will these work with the Link meter for Medtronic? Are they working on generics for the Bayer Contour next meters (also linked with Medtronic)?Thanks!

Hallie|2014-04-17

Thanks, Brent, this is spot on!There are many people with diabetes who currently don't have access to test strips, or at least don't have access to enough test strips, due to their high cost and to insurance limits. Even IF these test strips had reduced accuracy compared to the brand names, they still give you a lot more accurate picture of your blood sugar levels than you get when you don't have test strips at all! I, personally, am very excited about this development and only hope that many more companies follow with generic test strips in the future.

MikeH|2014-04-17

Thanks for the comment, Brent. It's definitely a balancing act, between low cost and accuracy/reliability. Think we all have to keep those things in mind. Interesting that you took that mention of Taiwan the way you did - I would've written the same whether it was Taiwan or anywhere in the U.S. My point was that OK BioTech is the same facility that Prodigy Diabetes uses in manufacturing its products, and that facility has been called out by the FDA. Of course, there is also the issue of how the FDA has also discussed concerns about overseas manufacturing facilities where the same inspection processes aren't always possible, but that's almost a side point to what I wrote.As to the future generics, you can see in the post that UniStrip told us they're working on more varities. There just aren't details on that right now, and it's currently only that OneTouch line they have generic strips for.

mcityrk|2014-04-17

Seems like for the currently low entry price on these strips that a multiple daily tester could run their own comparison studies of these new generics against their current strips simultaneously and come to their own conclusions as to whether they can be trusted. Of special interest of course would be the accuracy at both the low and high ends of the curve where inaccuracy is most problematic.

Dawn's Daddy|2014-04-17

Actually low end accuracy has not been a big problem for electro-chemical meters and strips since they were first introduced in the 1990s. It is the high end accuracy that presents a problem where the amount of glucose released chemically from the sample in reaction, adheres to the working strip electrodes with higher concentrations, usually beginning at 160-180 mg/dL creating a situation where the amount of free adherence space becomes more and more limited. Engineers that design meters call this noise, and the noise levels lower accuracy for higher end readings.

Tim Steinert|2014-04-18

I don't agree that reduced accuracy with more quantity of strips would give you a better picture of your blood sugar levels. I just had a sub-par A1c and trying to wade through the reasons why it happened would make Columbo envious of my powers of deduction. I had what I considered to be good numbers by the meter (and up to 5 a day!), but the picture the readings painted was inaccurate and had me scratching my head for a long time. The fewer variables I have to wade through the better. I came up with the brilliant idea of asking my endo if his medical group has a professional CGM that I can use to figure out what's going on (and slyly check my strip accuracy in the bargain). Thankfully, they do have a few CGMs and that data will help me track the problem down--but not everybody has access to the technology and have to depend upon strips alone.

Bennet|2014-04-18

Who is responsible if there is an issue?The company who makes the meter?The company who made the strip?The user, to prove it was a meter purchased before either Oct. 2012 or July 2010?FDA views these things as systems - meters strip and algorithms - to make it all work. Lowering cost is a good idea. With a generic medication patients can know who is responsible: the company who made it. I think that generic strips should have an agreement in place, as the FDA's proposed guidance suggests (line 990 of the over the counter document.) Agreements should be mandatory. Without agreements, the strip folks will point at the meter and the meter guys at the strip. Until they both figure out nobody can prove when they bought their meter, they will both blame the patient. There is too much blame the patient in diabetes already, we don't need to be inventing new ways of doing it. Generics, like branded systems, needs to come ALL THE WAY UP to new standards for accuracy, labeling, lot release and more.

Third Party Strips – Who is Accountable? – StripSafely|2014-04-18

[...] Update 4/17: Diabetes Mine‘s Mike H. has a full article with all kinds of interesting detail and reader comments on generics. Have a look. http://www.diabetesmine.com/2014/04/here-come-generics-test-strips-etc.html [...]

Mike Anderson|2014-04-18

Thanks for the comprehensive article Mike! Yes, it is always a balancing act between lower cost and reliability of test strips. But I'm not buying a Happy Meal at McDonalds. When it comes to managing my health, I will choose reliability and accurate test strip results over inexpensive or less reliable strips. We need to push all manufacturers, generics and big brands, to meet the same quality standard.The pending FDA draft guidelines on accuracy are still open for public commentary until May 7, 2014. In those guidelines, the FDA has specific language addressing quality measures third-party strip makers and that's something we, as a D-Community, should be supporting.

Laurie Dyer|2014-04-18

For the last year my daughter had been using the Relion prime test strips from Walmart. They are $9 for 50 strips and just as accurate as her One a touch Ultra. Even with insurance the a Relion strips were cheaper to buy over-the-counter. Why would anyone pay more? With a change in our insurance her strips are now 100% covered so we're back to the fancy "schmancy" brand.

Jen|2014-04-19

Urgh. Insurance companies are going to have fun with the generics. I've never had good luck with low cost meters and strips(some major brand names, too) - too many variables to contend with so they often don't work well for me. It's pathetic what the mail order companies that Medicare(or most insurance companies now) patients must contend with give - no name meters and strips with ridiculously crappy accuracy that only function in the accuracy guidelines on paper and cannot handle the variables.

Here Come Generics — Test Strips and a Ne...|2014-04-21

[...] It almost seems that a new era of alternative test strips and other "basic" diabetes products has hit. It's a sign of the times, really, as big-name brands are hurting because of Medicare competitive bidding changes that are limiting access to pricier products in favor of more economical options -- giving producers of generics a… [...]

Andy|2014-04-21

mcityrk,the problem with individuals doing comparison tests is that they don't have a standard to compare the results. every meter manufacturer, and the FDA, tells people not to compare one meter with another. if you used UniStrip1 test strips and OneTouch Ultra test strips with the same meter, how would you know which reading you should use to judge them? if one is 10% higher than the actual, and one is 10% lower than the actual, they are both well within the FDA standard----but 20% different. all meters have tolerances, and some tend to be biased toward high or low deviations. without the industry machine (YSI) used by most labs, the individual won't know which results are more accurate.

Andy|2014-04-21

Stephen and Readers,I'm disappointed to see the inaccuracies and incompleteness in this reporting. As Brent commented about the Taiwan reference, the author's bias and negativity toward these products is very apparent. As General Counsel to both companies, to whom the author refers, I feel the need to comment on the misrepresentations in this article. I continue to be astonished by the constant DOC attacks on Prodigy Diabetes Care, all arising from a FDA inspection in 2012 that did not include product defects or accuracy issues. The volume and tone of these attacks seem to be more in line with the marketing departments of the Big 4 than with unbiased reporters and patient advocates. I haven't seen a single article (other than a simple posting of the release) by this community that has raised general corporate or manufacturing concern about the THIRD recall of products by one Big 4 manufacturer in less than one year, let alone the multiple worldwide product recalls, and the practices reflected in pricing and other marketing investigations. It's not just Prodigy that says the 2012 inspection matter has been resolved, but the FDA conducted a full, unannounced inspection of Prodigy, and has posted a "closeout letter" on its website. Prodigy provided a copy of the Closeout Letter to the author prior to publication of this article. Instead of applying a negative spin on this issue, the author could have noted that the FDA grants closeout letters to fewer than 20% of the companies that receive warning letters, and highlighted the positive steps taken by Prodigy to address the FDA concerns.The author questions the accuracy of UniStrip1 test strips, but fails to provide any basis for doing so. The test results of the UniStrip1 with the J&J meters is public and available. As one of the commentors stated, the author could conduct a comparison test if the actual accuracy was important. (but a comparison test should be done properly) Instead, all the reader got was negative comments about the possibility that UniStrip might not be accurate. As for post-market surveillance, OK Biotech tests every lot of strips that it manufactures, and has used world-renowned labs to conduct third party tests of its products. No recall of test strips or meters manufactured by OK Biotech has been required --- can you say the same for the Big 4 manufacturers?The statement that Prodigy is "putting out questionable quality" in reference to a different Prodigy meter is patently false. I personally informed the author, prior to publication of the article, that, upon clearance of that meter by the FDA, Prodigy immediately notified the FDA that it would NOT market that product in the USA, and has not marketed that product. As with many products that arise from R&D and market tests, that product was terminated. To use it as the basis for a "questionable quality" comment and smear is wrong. And then applying that to a different company is reckless. For those readers interested in facts, OK Biotech is certified under the worldwide ISO standard for medical device manufacturers (13485) by the largest third party inspector in the world (TUV SUD), which is accredited by all EU nations and the FDA for third party audits. OK Biotech has been audited and certified by Canada's health agency. OK Biotech has also been inspected and certified by the Health & Welfare agency of Taiwan, one of the most advanced manufacturing nations in the world. OK Biotech similarly has invested in high-tech facilities, and opened its new state-of-the-art plant in May 2013. OK Biotech uses the same types of chemicals and components used by the Big 4 (most of which are also obtained and manufactured overseas). What should seem "shady" to caregivers, people with diabetes, and family, is that the Big 4 manufacturers have kept pricing in the USA at more than $1 per test strip for soooo many years, but sell the same products in Central and South America at prices comparable to that of UniStrip1. Look at pharmaceuticals---generic producers have brought billions of dollars of savings to the public in the area of drugs. The big pharmaceutical and device companies will continue to reap billions from all of us as long as they don't have competition....and negative articles without thorough investigation will continue to support them in doing so. Lower price does not mean lower quality. We invite all of the readers of diabetesmine and stripsafely, as well as all people with diabetes, to be the judges of UniStrip1 by UniStrip Technologies, and of Prodigy Diabetes Care products. These companies offer quality products at lower prices. Or, you can keep paying more than $1 per test strip, substantially higher insurance premiums, and know that the big pharma and medical device companies are secure.

Andy|2014-04-21

Mike,OK Biotech has not "been called out by the FDA". The issues raised by the FDA after its 2012 inspection of Prodigy were issues at Prodigy's facility in Charlotte, NC. The FDA made no observations or findings about OK Biotech. As you know, the FDA has issued a closeout letter to Prodigy after a full unannounced inspection of that facility in January 2014, indicating that its March 2012 concerns had been adequately resolved.Andy O'HaraProdigy Diabetes Care

Andy|2014-04-21

Bennet,UniStrip Technologies provides a full-service customer care center for its products, and is in compliance with all reporting requirements of the FDA.UniStrip Technologies, with reference to the current Draft Guidance, has asked LifeScan to enter into discussions on this matter, as strongly encouraged by the FDA. UniStrip Technologies will remain open to all opportunities to ensure patient safety, whether with the public or with other manufacturers.Andy at UniStrip

Bennet|2014-04-21

Hey AndyThanks for joining the conversation.My view and views like Your Diabetes, May Vary (- see how I did that?) is that agreements should be mandatory, just like post market inspections.I really worry about the cut off dates for meter production and how are users meant to know which meter is what vintage.Resolving those concern is certainly possible.An accurate tool, have value and an inaccurate one has none.

Andy|2014-04-21

UniStrip and OK Biotech are routinely monitoring the monitors.....Though the 510k indicates a date of October 2012 for UniStrip1 test strips, OK Biotech conducts routine testing of new strips with new meters and then updates the cutoff dates, which is reflected in the packaging/labeling, and is currently displayed clearly on the lable of UniStrip1 test strips as "before 2014". This process was addressed with the FDA pre-clearance, and is being done by the manufacturer post-clearance, which also provides effective and continuing "post-market surveillance" of the product.

Andy|2014-04-21

Brent,the UniStrip1 test strips are cleared by the FDA for use with the LifeScan OneTouch Ultra, Ultra2, UltraMini and UltraSmart. They are not cleared for use with any other blood glucose meter or system.

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